Chronic Hepatitis B
Conditions
Brief summary
A randomized study of ALG-125755 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics after single doses in healthy volunteers, and single and multiple doses in CHB subjects
Interventions
DRUGALG-125755
single or multiple doses of ALG-125755
DRUGPlacebo
single or multiple doses of placebo
Sponsors
Aligos Therapeutics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
for All Subjects: 1. Female subjects must have a negative serum pregnancy test at screening 2. Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria Inclusion Criteria for Healthy Subjects: 1. Male or female between 18 and 55 years of age, extremes included. 2. Subjects must have a body mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included. Inclusion Criteria for CHB Subjects (Parts 2 and 3): 1. Subjects must be 18 to 70 years of age, inclusive of extremes. 2. Subjects may have a BMI of 18.0 to 35.0 kg/m2, extremes included. 3. For virally suppressed subjects, must be currently receiving HBV NA treatment for ≥6 months prior to screening. For currently not treated or treatment naïve subjects, must have never received treatment OR have not been on treatment within 6 months prior to randomization
Exclusion criteria
for All Subjects: 1. Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation 2. Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc. 3. Subjects with a history of clinically significant drug allergy 4. Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment 5. Excessive use of alcohol defined as regular consumption of ≥14 standard drinks/week for women and ≥21 standard drinks/week for men 6. Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1 of various doses of ALG-125755 in HV subjects and CHB subjects | Up to 32 days for Part 1 |
| Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1 | Up to 52 days for Part 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to maximum plasma concentration [Tmax] | Predose (0 hours) up to 616 days | Pharmacokinetic parameters of ALG-125755 in plasma |
| Antiviral activity of ALG-125755 as measured by quantitative changes in serum | Predose (0 hours) up to 616 days | Pharmacokinetic parameters of ALG-125755 in plasma |
| Maximum plasma concentration (Cmax) | Predose (0 hours) up to 616 days | Pharmacokinetic parameters of ALG-125755 in plasma |
| Change in HBsAg from baseline through up to 112 days from last dose in multiple dose HBV infected subjects | screening to up to 112 days | — |
| Minimum plasma concentration (Cmin) | Predose (0 hours) up to 616 days | Pharmacokinetic parameters of ALG-125755 in plasma |
| Area under the concentration time curve [AUC] | Predose (0 hours) up to 616 days | Pharmacokinetic parameters of ALG-125755 in plasma |
Countries
Bulgaria, Moldova, New Zealand, Romania
Outcome results
None listed